• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceDERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL REPLACEMENT
Classification Namedressing, wound and burn, interactive
Generic Namedressing, wound and burn, interactive
Applicant
SHIRE REGENERATIVE MEDICINE
11095 torreyana road
san diego, CA 92121
PMA NumberP000036
Supplement NumberS003
Date Received11/17/2003
Decision Date12/15/2003
Product Code
MGR
Advisory Committee General & Plastic Surgery
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the addition of a direct culture-based 28-day procedure for mycoplasma detection before dermagraft product release.
-
-